Quality

Reliability is engineered, measured and recorded.

Seven ISO 13485-certified, FDA-registered facilities and electro-mechanical cleanrooms rated ISO Class 7 and 8.

ISO 13485

Medical device quality management

FDA

Registered manufacturing facilities

ISO 7 / 8

Electro-mechanical cleanrooms

IQ/OQ/PQ

Validated process methodology

Part-level traceability

Every part's quality history is continuously recorded against OEM specification.

Data collection at each machining and assembly step catches drift before it becomes scrap.

Leak, flow, pressure and actuation testing on qualified sub-assemblies.

IQ/OQ/PQ methodology for regulated and sterile products.